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US FOOD AND DRUG ADMINISTRATION (USFDA) NEWS

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UK general practitioners may use extra COVID-19 vaccine doses at discretion: NHS

December 18, 2020 9:02 am

The National Health Service (NHS) confirmed to Reuters that in a weekly webinar with NHS England on Thursday, clinicians were told they could use the sixth dose "at their discretion".

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US regulator doubled warnings to Indian drugmakers last year

January 21, 2020 11:46 am

The sanctions may delay about 18 per cent of new products Indian companies were planning to introduce in the US, according to a report Monday from Crisil Ltd, the local unit of S&P Global Ratings.

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USFDA warns Emcure Pharma for ‘failing’ to ‘adequately investigate’ injection sterility issues

August 17, 2019 2:32 am

The regulator has pointed out that Emcure “failed” to “adequately investigate” these sterility failures, adding that this is not the first time it uncovered such findings at the firm’s facility.

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Glenmark Pharma gets tentative nod from USFDA for acne treatment drug

June 20, 2019 11:18 am

Glenmark Pharmaceuticals, USA, has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Foam, 1 per cent, the company said in a BSE filing.

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Teva Pharmaceutical: Shares rise after FDA approves new migraine drug

September 15, 2018 11:49 am

Shares of Teva, which rose 2.9 percent to close at $22.85 in regular trading, were up another 5.4 percent at $24 after hours.

Dr Reddy’s to USFDA: Staff giving illogical answers not appropriate

Two DRL officials had sought removal of USFDA’s adverse observations

June 13, 2018 1:20 am

In the report, one of the USFDA inspectors wrote: “Mr Toshniwal and Mr Reddy Kallam requested that I remove the observations from the FDA-483.

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USFDA observations: ‘Mosquitoes, gnats in Alkem plant; no quality control unit’

April 13, 2018 2:42 am

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection if investigators find violations of US drug laws.

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US FDA approves first digital ingestion tracking system drug to ensure prescriptions

November 14, 2017 6:49 pm

The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them.

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USFDA to lift import alert on Vizag unit: Divi's Labs

November 02, 2017 3:01 pm

In March this year, Divi's Labs said USFDA had issued import alert under clauses 99-32 and 66-40, and a warning letter later for the Visakhapatnam facility for non-compliance of good manufacturing practice (GMP) norms.

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Apple, Fitbit to join FDA program to speed health tech

September 27, 2017 8:24 pm

The Food and Drug Administration said Tuesday that it had selected nine major tech companies for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products.